|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
10 October 2016 |
|
Main ID: |
NCT02041780 |
|
Date of registration:
|
20/01/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy
SHEARWAVE |
|
Scientific title:
|
Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy |
|
Date of first enrolment:
|
November 2013 |
|
Target sample size:
|
220 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02041780 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Stéphanie FRANCHI-ABELA, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Assistance Publique - Hôpitaux de Paris |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- age < 18 years;
- indication to liver biopsy;
- informed consent of both parents and child if applicable;
- social insurance
Exclusion Criteria:
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Liver Fibrosis
|
|
Children
|
|
Intervention(s)
|
|
Procedure: Shearwave electrography
|
|
Primary Outcome(s)
|
|
liver fibrosis evaluated by the ISHAK score and morphometric evaluation
[Time Frame: up to 1 month]
|
|
Secondary Outcome(s)
|
|
liver fibrosis evaluation : stiffness using SHEARWAVE elastography
[Time Frame: up 1 month]
|
|
Liver fibrosis evaluation using Fibrotest (Fibromax)
[Time Frame: up 1 month]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|